Apparatus and method for intravascular measurements

ABSTRACT

Intravascular diagnosis apparatus and methods are disclosed. In one aspect of the disclosed technology, a intravascular diagnosis apparatus includes a monitoring guidewire and a display unit. The monitoring guidewire includes a core wire and a sensor disposed in a distal region of the core wire. The display unit includes a processor and a display screen, and is capable of receiving communication from the monitoring guidewire. The display unit is configured to perform computations using the processor based on communications received from the monitoring guidewire and is configured to display information on the display screen based on the computations. The display unit can be configured to be disposed after a predetermined number of uses or after a predetermined duration of use.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/321,776, filed Jul. 1, 2014, which claims priority to U.S.Provisional Application No. 61/985,858, filed Apr. 29, 2014, and to U.S.Provisional Application No. 61/841,517, filed Jul. 1, 2013. The entirecontents of each and every priority application are hereby incorporatedby reference herein.

FIELD OF THE INVENTION

The disclosed technology relates to intravascular diagnosis. Moreparticularly, the disclosed technology relates to diagnosing theseverity of stenosis in the vasculature of a patient.

BACKGROUND

Reduced blood flow due to atherosclerotic occlusion of vessels is amajor cause of vascular diseases. Pressure measurements in arterialvessels and particularly in coronary arteries prior to treatment havebeen used for lesion characterization and treatment selection. Morespecifically, pressure gradient across a lesion has been clinically usedas an indicator for lesion severity. Measurements made during and aftertreatment allow one to assess therapy efficacy. Existing equipment formonitoring intravascular measurements have multiple, separate parts andbulky monitors. There is, accordingly, continuing interest in improvedmonitoring equipment.

SUMMARY

The disclosed technology relates to diagnosing the severity of stenosesin the vasculature of a patient.

In one aspect of the disclosed technology, an apparatus forintravascular diagnosis includes a monitoring guidewire having a corewire and a sensor disposed in a distal region of the core wire, and aportable display unit configured to be disposed after a predeterminednumber of uses or after a predetermined duration of use. The portabledisplay unit can include a processor and a display screen, where theportable display unit is capable of receiving communication from themonitoring guidewire, is configured to perform computations using theprocessor based on communications received from the monitoringguidewire, and is configured to display information on the displayscreen based on the computations.

In one embodiment, the portable display unit includes one or morebatteries configured to power the portable display unit. In oneembodiment, the one or more batteries can be rechargeable by a powersource of the portable display unit and/or a power source external tothe portable display unit.

In one embodiment, the portable display unit further includes one ormore batteries configured to power the portable display unit for apredetermined duration of use, such that the portable display unit canbe configured to be disposed after the one or more batteries aredepleted. In one embodiment, the one or more batteries arenon-rechargeable. In one embodiment, the portable display unit can beconfigured to be inoperable after a one uses.

In one aspect of the disclosed technology, the monitoring guidewire canbe configured to be disposed after a single use.

In one embodiment, the portable display unit and the monitoringguidewire can communicate wirelessly. In one embodiment, the portabledisplay unit includes a connector configured to establish acommunicative connection with the monitoring guidewire. In oneembodiment, the connector is configured to establish a mechanicalconnection with the monitoring guidewire to control the guidewire withina vasculature. In one embodiment, a torquer is configured to engage themonitoring guidewire to control the guidewire within a vasculature.

In one embodiment, the monitoring guidewire includes a housingsurrounding the sensor, and the housing can be laser etched to provideflexibility for the housing. In one embodiment, the monitoring guidewireincludes a flexible coil surrounding the sensor, with the coil having arelaxed portion over the sensor.

In one aspect of the disclosed technology, the sensor is a pressuresensor and communication from the monitoring guidewire includesmeasurements from the pressure sensor. The processor of the portabledisplay unit is capable of computing fractional flow reserve based onpressure measurements from only the pressure sensor in the distal regionof the core wire.

In one embodiment, the fractional flow reserve is a push-forwardfraction flow reserve (“FFR”) computed as:FFR=(P_(sensor)−P_(ra))/(P_(saved)−P_(ra)), where:

P_(saved) are moving means over time of recorded pressure measurementsproximal to a first stenosis,

P_(sensor) are moving means over time of real time pressure measurementsdistal to the first stenosis, and

P_(ra) is a constant.

In one embodiment, P_(saved) are moving means over time of recordedpressure measurements proximal to the first stenosis and proximal to asecond stenosis. In one embodiment, P_(sensor) are moving means overtime of real time pressure measurements distal to the first stenosis andproximal to a second stenosis. In one embodiment, P_(sensor) movingmeans over time of real time pressure measurements distal to the firststenosis and distal to the second stenosis.

In one embodiment, the fractional flow reserve is a pull-back fractionflow reserve computed as: FFR=(P_(saved)−)/(P_(sensor)−P_(ra)), where:

P_(saved) are moving means over time of recorded pressure measurementsdistal to a first stenosis,

P_(sensor) are moving means over time of real time pressure measurementsproximal to the first stenosis, and

P_(ra) is a constant.

In one embodiment, P_(sensor) are moving means over time of real timepressure measurements proximal to the first stenosis and distal to asecond stenosis. In one embodiment, P_(saved) are moving means over timeof recorded pressure measurements distal to the first stenosis anddistal to a second stenosis. In one embodiment, P_(sensor) are movingmeans over time of real time pressure measurements proximal to the firststenosis and proximal to the second stenosis.

In one embodiment, the portable display unit displays on the displayscreen the fractional flow reserve. In one embodiment, the portabledisplay unit displays a graph of the pressure measurements.

In one embodiment, the portable display unit includes a communicationsport configured to receive communications that include pressuremeasurements.

In one embodiment, the fractional flow reserve is a pull-back fractionflow reserve computed as: FFR=(P_(sensor)−P_(ra))/(P_(port)−P_(ra)),where:

P_(port) are moving means over time of real-time pressure measurementsreceived at the communications port,

P_(sensor) are moving means over time of real-time pressure measurementsfrom the pressure sensor disposed in the distal region of the core wire,and

P_(ra) is a constant.

In one embodiment, the portable display unit is configured withcapability to compute fractional flow reserve in at least two ways:computing fractional flow reserve based on pressure measurements fromonly the pressure sensor disposed in the distal region of the core wire,and computing fractional flow reserve based on the pressure measurementsfrom the pressure sensor and based on pressure measurements received ata communications port. In one embodiment, the portable display unit canbe configured to automatically use one of the at least two ways ofcomputing fractional flow reserve. In one embodiment, the portabledisplay unit can be configured to automatically select one of the waysof computing fractional flow reserve when a condition is present and canbe configured to automatically select another of the at least two waysof computing fractional flow reserve when the condition is absent. Inone embodiment, the portable display unit can be configured to permit auser to manually select one of the at least two ways of computingfraction flow reserve.

In one aspect of the disclosed technology, an apparatus forintravascular diagnosis includes a monitoring guidewire having a corewire and a sensor disposed in a distal region of the core wire, and ahandheld display unit configured to be disposed after a predeterminednumber of uses or after a predetermined duration of use. The handhelddisplay unit can include a processor and a display screen, where thehandheld display unit is capable of receiving communication from themonitoring guidewire, is configured to perform computations using theprocessor based on communications received from the monitoringguidewire, and is configured to display information on the displayscreen based on the computations. In one embodiment, the handhelddisplay unit can be equal to or less than 30 cm×30 cm×30 cm in size.

In one aspect of the disclosed technology, an apparatus forintravascular diagnosis includes a monitoring guidewire having a corewire and a sensor disposed in a distal region of the core wire, and aportable display unit capable of receiving communication from themonitoring guidewire. The portable display unit includes a processor anddisplay screen, and is configured to perform computations using theprocessor based on communications received from the monitoring guidewireand is configured to display information on the display screen based onthe computations. The portable display unit has no capability of beingturned off after the display screen is turned on,

These aspects and embodiments of the disclosed technology are exemplaryand do not limit the scope of the disclosed technology, which will beapparent from a reading of the following detailed description and theassociated drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of an exemplary intravascular diagnosisapparatus in accordance with the disclosed technology.

FIG. 2 is a block diagram of an embodiment of the disclosed technology;

FIG. 3 is a diagram of an exemplary apparatus in accordance with thedisclosed technology;

FIG. 4 is another diagram of an exemplary apparatus in accordance withthe disclosed technology;

FIG. 5 is a diagram of an exemplary distal tip of the disclosedmonitoring guidewire;

FIG. 6 is a diagram of two embodiments of the distal tip of thedisclosed monitoring guidewire;

FIG. 7 is a diagram of one position for the disclosed monitoringguidewire for estimating fractional flow reserve;

FIG. 8 is a diagram of another position for the disclosed monitoringguidewire for estimating fractional flow reserve;

FIG. 9 is a flow diagram of exemplary operation of the disclosedtechnology for computing simultaneous fractional flow reserve;

FIG. 10 is a flow diagram of exemplary operation of the disclosedtechnology for computing push-forward fractional flow reserve; and

FIG. 11 is a flow diagram of exemplary operation of the disclosedtechnology for computing pull-back fractional flow reserve.

DETAILED DESCRIPTION

The disclosed technology relates to diagnosing the severity of stenosisin the vasculature of a patient. The disclosed technology can be used asan adjunct to conventional angiographic procedures to provide importantquantitative measurements of a blood vessel lumen.

Referring now to FIG. 1, there is shown a block diagram of an exemplaryintravascular diagnosis apparatus in accordance with the disclosedtechnology. The illustrated apparatus 100 includes a monitoringguidewire 102 and a portable display unit 104. In one embodiment, theportable display unit 104 can be a handheld display unit, such that anyand all aspects and embodiments described herein as being applicable toa portable display unit are also applicable to the disclosed handhelddisplay unit. In one embodiment, the handheld display unit can be equalto or less than 30 cm×30 cm×30 cm in size. In operation, the monitoringguidewire 102 is introduced into the vasculature of a patient with theassistance of conventional interventional equipment known to thoseskilled in the art, such as catheters. The portable display unit 104 cancommunicate with the monitoring guidewire 102 and can displayinformation based on the communications received from the monitoringguidewire 102.

The illustrated monitoring guidewire 102 can include several components,including a core wire 106 and one or more sensors 108 disposed in adistal region of the core wire 106. As used herein, the terms “distal”and “proximal” refer to physical directions within a blood vessel lumen.Specifically, in relation to the insertion point of a device into apatient, the term “distal” refers to the direction from the insertionpoint inwards into a blood vessel, and the term “proximal” refers to thedirection from the inside of a blood vessel out towards the insertionpoint. As used herein, the terms “proximal” and “distal” can also referto different ends of a device, with “proximal” being the end towards aninsertion point into a blood vessel lumen and with “distal” being theend away from the insertion point.

With continuing reference to FIG. 1, the one or more sensors 108disposed in a distal region of the core wire 106 can include one or morehemodynamic pressure sensors and/or one or more temperature sensors. Inone embodiment, the pressure sensor(s) can be a piezo-resistive pressuresensor. As illustrated in FIG. 1, the monitoring guidewire 102 can alsoinclude a protective structure 110 surrounding the sensor(s) 108, andcan include a communication unit 112. The protective structure 110 ofthe monitoring guidewire 102 will be described in more detail laterherein in connection with FIGS. 5-6.

In one embodiment, the communication unit 112 can employ wirelesscommunication technology such as bluetooth, WiFi (802.11), or any otherwireless technology. In one embodiment, the communication unit 112 canbe a wireline communication unit that can include one or more wires forcommunicating electromagnetic signals and/or one or more optical fibersfor communicating optical signals. The monitoring guidewire 102 caninclude other components that are not illustrated, such as a powersource, A/D converters, application specific integrated circuits (ASIC),a processor, memory, timing circuitry, and/or other power, analog, ordigital circuitry. Such components will be known to those skilled in theart.

Referring now to the illustrated portable display unit 104, the portabledisplay unit 104 can include a display screen 114, one or more batteries116, memory and/or storage 118, a communication unit 120, powermanagement unit 122, and a processor 124. In one embodiment, theprocessor 124 can be a general purpose processor or can be anapplication specific integrated circuit. In one embodiment, the displayscreen 114 can be a liquid crystal display, an organic light emittingdiode display, or another type of display technology. In one embodiment,the memory/storage 118 can include one or more of solid statememory/storage, magnetic disc storage, and/or any other type ofmemory/storage that will be known to those skilled in the art. In oneembodiment, the memory/storage 118 can include software instructionsthat are executed by the processor 124. In one embodiment, thecommunication unit 120 can employ wireless communication technology suchas bluetooth, WiFi (802.11), or any other wireless technology. In oneembodiment, the communication unit 120 can be a wireline communicationunit that can include one or more wires for communicatingelectromagnetic signals and/or one or more optical fibers forcommunicating optical signals. The portable display unit 104 can includeother components that are not illustrated, such as user interface,operating system software, display driver circuitry, A/D converters,application specific integrated circuits (ASIC), timing circuitry,and/or other power, analog, or digital circuitry. Such components willbe known to those skilled in the art.

Referring now to FIG. 2, there is shown a system block diagram ofanother embodiment of the disclosed technology. The monitoring guidewirecontains a pressure sensor and/or other sensors at the distal end. Theelectrical signals from the sensor(s) can be sent over a wire connectionto the portable display unit. The portable display unit can include acommunications port that receives external sensor input such as aorticoutput pressure (AO IN) from pressure transducers/hemodynamic systems(not shown). The portable display unit can also include an outputcommunication port for outputting data to an external storage device, toanother display, to a printer, and/or to a hemodynamic system (notshown).

Referring now to FIG. 3, there is shown an exemplary embodiment of thedisclosed intravascular diagnosis apparatus. In one embodiment, themonitoring guidewire 302 can be approximately 180 centimeters in length.In other embodiments, the monitoring guidewire 302 can be anotherlength. The monitoring guidewire 302 can have one or more sensors in thedistal region 304 of the monitoring guidewire 302. In the illustratedembodiment, the portable display unit 306 can have a small form factorsuch that it is a handheld display unit. In one embodiment, a handhelddisplay unit can be equal to or less than 30 cm×30 cm×30 cm in size.

FIG. 4 is a diagram of another exemplary embodiment of the disclosedintravascular diagnosis apparatus. In the illustrated embodiment, themonitoring guidewire 402 can be attached and detached from a connector406 of the portable display unit 400. In one embodiment, the connector406 can include a button (not shown) which opens an aperture in theconnector 406. To attach or detach the monitoring guidewire 402, a usercan press and hold the button of the connector 406 and insert themonitoring guidewire 402 into the aperture until the monitoringguidewire 402 is fully inserted into connector 406. Once inserted, theuser can release the button, which will then secure the monitoringguidewire 402 in place and provide a connection between the monitoringguidewire 402 and connector 406. In other embodiments, the connector 406can engage the monitoring guidewire 402 by a screw engagement, a twistengagement, a snap engagement, or an interference fit. The describedtypes of engagement are exemplary and do not limit the scope of thedisclosed technology. Other types of ways for the connector 406 toengage the monitoring guidewire 402 are contemplated to be within thescope of the disclosed technology.

In one embodiment, the connector connection establishes a communicativeconnection between the monitoring guidewire 402 and the portable displayunit 400. The monitoring guidewire 402 and the connector 406 can containelectrical wires that connect the monitoring guidewire 402 to theportable display unit 400 and convey signals from the monitoringguidewire sensor(s) to the portable display unit 400.

In one embodiment, the connector connection establishes a mechanicalconnection between the monitoring guidewire 402 and the connector 406 tocontrol the guidewire 402 within a vasculature. In the illustratedembodiment, the connector 406 is tethered to the main housing 410 of theportable display unit 400. In one embodiment, the tether can be 6 inchesto 12 inches long and can allow a user to manipulate the monitoringguidewire 402 freely without the portable display unit main housing 410being an impediment. In one embodiment, the tether can be anotherlength. In one embodiment (not shown), the connector can be a connectionport integrated in the portable display unit main housing 410.

In one embodiment, the connector 406 establishes a communicativeconnection with the monitoring guidewire 402. In one embodiment, atorquer (not shown) can be configured to engage the monitoring guidewire402 to control the guidewire within a vasculature when the monitoringguidewire 402 is not mechanically and/or electrically connected to theconnector 406. In one embodiment, the torquer can be configured toengage the monitoring guidewire 402 to control the guidewire within avasculature when the monitoring guidewire 402 is mechanically and/orelectrically connected to the connector 406. In one embodiment, themonitoring guidewire 402 does not need a torquer or the connector 406for insertion into the vasculature of a patient and for navigationtherein, and provides this capability by itself.

With continuing reference to FIG. 4, the portable display unit 400includes a display screen 404 that can display sensor measurementsand/or computed information (e.g., fractional flow reserve ratio), innumerical format and/or in waveform format. The portable display unit400 can include one or more buttons (not shown) or a touch screen toallow a user to provide input to the portable display unit 400. In oneembodiment, the screen 404 of the portable display unit can be folded inthe main housing 410 before use to minimize the size of packaging whendelivering the portal display unit 400. When a user takes the portabledisplay unit 400 out of the packaging for use, the user can pivot thescreen 404 from the folded position to an open position (asillustrated), providing an appropriate viewing angle to the user for thediagnosis procedure. In one embodiment, pivoting of the display screen404 from the folded position to an open position acts as an ON switchthat enables power to be delivered to the portable display unit.

In the illustrated embodiment, the portable display unit 400 alsoincludes a communication port 408. In one embodiment, the communicationport 408 allows a user to connect the portable display unit 400 to anexternal system (not shown). The external system can communicate asensor signal to the portable display unit 400 through the communicationport 408. In one embodiment, the sensor signal received at thecommunication port can be can be a pressure measurement and can be usedin calculating fractional flow reserve.

Referring again to FIG. 1, the monitoring guidewire 102 can include aprotective structure 110 surrounding the sensor(s) 108. With referenceto FIG. 5, there is shown a diagram of an exemplary protective structure502 surrounding the sensor(s) 510 at the distal region of the monitoringguidewire. In the illustrated embodiment, the protective structure 502is a housing that has been laser etched with a particular pattern cut toprovide flexibility and/or torque translation at the distal tip orportion of the monitoring guidewire where the sensor 510 resides. Thesensor(s) 510 can be situated in the laser etched housing at a window504 in the housing so as to allow blood to contact the sensor(s) 510 inorder to take sensor measurements. In the illustrated embodiment, thecore wire 508 can be grinded to provide an appropriate profile forbalancing flexibility and torque translation. In one embodiment, themonitoring guidewire need not include a core wire 508. Rather, theprotective structure 502 can extend along the entire monitoringguidewire or a substantial portion thereof, and can be laser etchedalong some or all portions to provide desired flexibility and/or torquetranslation.

Referring to FIG. 6, there is shown a diagram of two exemplaryprotective structures surrounding the sensor(s) at the distal region ofa monitoring guidewire. One of the embodiments is a laser etched housingas described in connection with FIG. 5. The other embodiment provides acoil over the sensor(s) as the protective structure. The coil is relaxedto create a window where the sensor(s) are located to allow blood tocontact the sensor(s). The illustrated embodiments are exemplary and donot limit the scope of protective structures contemplated in thedisclosed technology. Other protective structures are contemplated to bewithin the scope of the disclosed technology.

Various aspects and embodiments of the disclosed technology have beendescribed above. The illustrations and descriptions are merely exemplaryand do not limit the scope of the disclosed technology. Even though notillustrated, various embodiments can be combined and are contemplated tofall within the scope of the disclosed technology. Furthermore, althoughcertain features are illustrated as being in a particular location ordevice, the location and device are merely exemplary, and it iscontemplated that various features can be located differently than asillustrated and still be within the scope of the disclosed technology.

The following description will now reference FIG. 1, and in particular,the battery 116 and the power management unit 122 of the portabledisplay unit 104. In one aspect of the disclosed technology, theportable display unit 104 can be configured to operate for apredetermined duration or for a predetermined number of uses, and thenbe disposed. The battery 116 and/or power management unit 122 canimplement these features so that the portable display unit 104 can beinoperable after being used for a particular duration or for aparticular number of diagnosis procedures. Even so, the portable displayunit 104 can be disposed while it is still operable, prior to it beinginoperable.

In one embodiment, the predetermined duration can correspond to theapproximate length of time of a single intravascular diagnosisprocedure. In one embodiment, the predetermined duration can correspondto the approximate length of time of multiple diagnosis procedures, suchas three procedures. In one embodiment, the predetermined duration canbe twelve hours or twenty-four hours or several days. In one aspect ofthe disclosed technology, the portable display unit 104 can include oneor more batteries 116 that are configured to power the portable displayunit 104 for the desired duration, such that the batteries 116 aresubstantially depleted at the end of the desired duration. In oneembodiment, the one or more batteries 116 are non-rechargeable, so thatthe portable display unit 104 is disposed after the batteries 116 aredepleted. In one embodiment, the power management unit 122 can controlthe operating time of the portable display unit 104 by preventing theportably display unit 104 from powering down after the display screen114 is turned on. In such an embodiment, the portable display unit 104will operate continuously until the batteries 116 are depleted orsubstantially depleted. The portable display unit 104 can be disposedprior to the batteries 116 being depleted, while the portable displayunit 104 is still operable.

In one embodiment, the portable display unit 104 can track the number ofdiagnosis procedures performed and can be configured to be inoperableafter a particular number of procedures has been performed. In oneembodiment, the portable display unit 104 can track the number ofdiagnosis procedures performed by the number of times the portabledisplay unit 114 has been turned on and/or off. In one embodiment, theportable display unit 104 can be configured to be inoperable after asingle diagnosis procedure has been performed. In one aspect of thedisclosed technology, the power management unit 122 can prevent theportable display unit 104 from being powered on after the particularnumber of procedures has been reached. The batteries 116 can berechargeable and can be recharged by a power source of the portabledisplay unit 104 and/or by a power source external to the portabledisplay unit 104. Even when the batteries 116 are not yet depleted, thepower management unit 122 can cause the portable display unit 104 to beinoperable by preventing the batteries 116 from powering the portabledisplay unit 104.

The intravascular diagnosis procedure will now be described withcontinuing reference to FIG. 1 and with reference to FIGS. 7-11.Diagnosing the severity of one or more stenoses within the vasculatureof a patient has been studied based on hemodynamic pressure measurementsdistal to a stenosis in comparison with aortic output pressure. Theratio of pressure distal to a stenosis to the aortic output pressure isknown as “factional flow reserve”, or FFR. The value of the FFRindicates the severity of the stenosis, and clinical data providesguidance on the type of surgical procedure that would be effective forparticular FFR ranges.

The disclosed technology includes multiple ways of computing FFR,including what will be referred to herein as “push-forward FFR”,“pull-back FFR”, and “simultaneous FFR”. Each of these can beimplemented by software code or machine code stored in memory/storage118 of the portable display unit 104 (FIG. 1). The processor 124 canexecute the software code to compute the FFR, and the resultinginformation can be displayed on the display screen 114. Each of thecomputation methods will now be described.

Simultaneous Fraction Flow Reserve

Simultaneous FFR involves simultaneous pressure readings from twoseparate pressure sensors, and a computation of FFR in real-time as thepressure readings from the two separate pressure sensors are received.Referring to FIG. 1 and FIG. 9, one pressure sensor is located in themonitoring guidewire 102, and is used to measure pressure distal to astenosis in a patient. The pressure readings can be communicated by thecommunication unit 112 of the monitoring guidewire 102 to thecommunication unit 120 of the portable display unit 104 (902). Thiscommunication can be a wireless communication or can be a wirelinecommunication through, for example, the connector illustrated in FIG. 3.The other pressure sensor can measure aortic output pressure and isexternal to the apparatus 100 of FIG. 1. The portable display unit 104can designate the received pressure measurements as pressure distal to astenosis (904). The external sensor readings can be communicated to thecommunication unit 120 of the portable display unit by, for example, thecommunication port illustrated in FIG. 3 (906). The portable displayunit 104 can designate the received pressure measurements as pressureproximal to a stenosis (908). The portable display unit 104 can computethe simultaneous FFR as the pressure measurements are received (910), bythe formula: FFR=(P_(sensor)−P_(ra))/(P_(port)−P_(ra)), where:

P_(port) are moving means over time of real-time pressure measurementsreceived at the communications port,

P_(sensor) are moving means over time of real-time pressure measurementsfrom the pressure sensor in the distal region of the core wire of themonitoring guidewire, and

P_(ra) is a constant, which can be zero or another constant value.

In one embodiment, the moving means over time can compute the mean overa window of time that spans one heartbeat. In other embodiments, thewindow of time can span less than one heartbeat or more than oneheartbeat. As new sensor measurements are received over time (902, 906),the window can include newer measurements and remove older measurementsto compute the moving means.

The portable display unit 104 can receive pressure measurements and cancompute the simultaneous FFR based on the received measurements. Theportable display unit 104 can store the received pressure measurementsand/or the computed simultaneous FFR in memory/storage 118, and candisplay the computed simultaneous FFR and/or a graph of the receivedpressure measurements on the display screen 114 (912).

Push-Forward Fractional Flow Reserve

In contrast to simultaneous FFR, the push-forward FFR does not receiveexternal pressure measurements. With continuing reference to FIG. 1,push-forward FFR is computed using pressure measurements from only thepressure sensor(s) 108 in the distal region of the monitoring guidewire102. Using traditional angiography, a stenosis can be located and, asshown in FIG. 8, the monitoring guidewire can be inserted into a patientto a point proximal to the stenosis. Pressure can be measured at thisposition by the sensor(s) 108 and communicated by the communication unit112 to the portable display unit 104 (1002). The portable display unit104 can store the measurements in this position in the memory/storage118 as pressure proximal to a stenosis (1004). Next, the monitoringguidewire 102 can be pushed forward past the stenosis to a point distalto the stenosis, as illustrated in FIG. 7. Pressure can be measured atthis position by the sensor(s) 108 and communicated by the communicationunit 112 to the portable display unit 104 (1006). The portal displayunit 104 can designate the pressure measurements received at thisposition as pressure distal to the stenosis (1008). The processor 124can compute the push-forward FFR (1010) by the formula:FFR=(P_(sensor)−P_(ra))/(P_(saved)−P_(ra)), where:

P_(saved) are moving means over time of recorded pressure measurementsproximal to the stenosis,

P_(sensor) are moving means over time of real time pressure measurementsdistal to the stenosis, and

P_(ra) is a constant, which can be zero or another constant value.

Aspects of computing the moving means over time were described above inconnection with simultaneous FFR, and such aspects apply to push-forwardFFR as well.

The portal display unit 104 can display the computed push-forward FFRand/or a graph of the received and stored pressure measurements (1012).

Push-forward FFR can be computed in the case of one stenosis and canalso be computed in the case of multiple stenosis. In either case,P_(saved) are moving means over time of pressure measurements proximalto all of the stenosis. In one embodiment, P_(saved) are moving meansover time computed based on recorded pressure measurements. In oneembodiment, P_(saved) are moving means over time computed and recordedas pressure measurements are received, and the pressure measurements mayor may not be recorded. For example, in the case of two stenoses,P_(saved) are based on pressure measurements proximal to both the firstand second stenosis. When the monitoring guidewire pressure sensor 108is pushed forward to a position between the first and the secondstenosis, P_(sensor) are based on real time pressure measurementsbetween the two stenoses. Push-forward FFR can be calculated in thisposition and displayed on the display screen 114. When the monitoringguidewire pressure sensor 108 is pushed forward to a position distal toboth the first and second stenoses, P_(sensor) are based on real timepressure measurements distal to both of the two stenoses. Push-forwardFFR can be calculated in this position and displayed on the displayscreen 114. Thus, push-forward FFR enables FFR to be computed anddisplayed as the monitoring guidewire 102 is pushed forward across oneor more stenoses in a blood vessel lumen. The only measurements and/ormoving means that need to be recorded for push-forward FFR computationsare pressure measurements and/or moving means of pressure measurementsproximal to all stenoses, and this is performed at the outset.

Pull-Back Fractional Flow Reserve

Similar to push-forward FFR, the pull-back FFR does not receive externalpressure measurements. Rather, pull-back FFR is computed using pressuremeasurements from only the pressure sensor(s) 108 in the distal regionof the monitoring guidewire 102. Using traditional angiography, astenosis can be located and, as shown in FIG. 7, the monitoringguidewire can be inserted into a patient to a point distal to thestenosis. Pressure can be measured at this position by the sensor(s) 108and communicated by the communication unit 112 to the portable displayunit 104 (1102). The portable display unit 104 can store themeasurements in this position in the memory/storage 118 as pressuredistal to a stenosis (1104). Next, the monitoring guidewire 102 can bepulled back through the stenosis to a point proximal to the stenosis, asillustrated in FIG. 8. Pressure can be measured at this position by thesensor(s) 108 and communicated by the communication unit 112 to theportable display unit 104 (1106). The portable display unit 104 candesignate the measurements received in this position as pressureproximal to a stenosis (1108). The processor 124 can compute thepull-back FFR (1110) by the formula:

FFR=(P _(saved) −P _(ra))/(P _(sensor) −P _(ra))

where:

P_(saved) are moving means over time of recorded pressure measurementsdistal to the stenosis,

P_(sensor) are moving means over time of real time pressure measurementsproximal to the stenosis, and

P_(ra) is a constant, which can be zero or another constant value.

Aspects of computing the moving means over time were described above inconnection with simultaneous FFR, and such aspects apply to pull-backFFR as well.

The portal display unit 104 can display the computed pull-back FFRand/or a graph of the received and stored pressure measurements (1112).

Pull-back FFR can be computed in the case of one stenosis and can alsobe computed in the case of multiple stenosis. In either case, P_(sensor)are based on real-time pressure measurements proximal to all of thestenosis, which are the final pressure measurements that are taken. Forexample, in the case of two stenoses, the monitoring guidewire pressuresensor 108 is initially placed at a position distal to both the firstand the second stenoses. Pressure can be measured at this position bythe sensor(s) 108 and communicated by the communication unit 112 to theportable display unit 104. In one embodiment, P_(saved_d1) are movingmeans over time computed later based on recorded pressure measurements.In one embodiment, P_(saved_d1) are moving means over time computed andrecorded while the pressure measurements are received in this position,and the pressure measurements may or may not be recorded. Thememory/storage 118 can record the pressure measurements in this positionand/or computed moving means over time based on such pressuremeasurements. Pull-back FFR cannot yet be calculated because there is noreal-time measurement yet proximal to all of the stenoses. Next, themonitoring guidewire 102 can be pulled back through the first stenosisto a point between the first and second stenosis. Pressure can bemeasured at this position by the sensor(s) 108 and communicated by thecommunication unit 112 to the portable display unit 104. In oneembodiment, P_(saved_d2) are moving means over time computed later basedon recorded pressure measurements. In one embodiment, P_(saved_d1) aremoving means over time computed and recorded while the pressuremeasurements are received in this position, and the pressuremeasurements may or may not be recorded. The memory/storage 118 canrecord the pressure measurements in this position and/or computed movingmeans over time based on such pressure measurements. Once again,pull-back FFR cannot yet be calculated because there is no real-timemeasurement yet proximal to all of the stenoses. Lastly, the monitoringguidewire 102 can be pulled back through the second stenosis to a pointproximal to both the first and second stenosis. Real-time pressure canbe measured at this position by the sensor(s) 108 and communicated bythe communication unit 112 to the portable display unit 104. Only atthis point are there enough measurements to compute the two pull-backFFR: FFR₁=(P_(saved_d1)−P_(ra))/(P_(sensor)−P_(ra)) andFFR₂=(P_(saved_d2)−P_(ra))/(P_(sensor)−P_(ra)). Therefore, pull-back FFRdoes not allow FFR to be calculated and displayed as the monitoringguidewire is being pulled back through multiple stenoses.

Accordingly, three computations for fractional flow reserve have beendescribed above in connection with FIGS. 7-11. In one aspect of thedisclosed technology, and with reference to FIG. 1, the portable displayunit 104 is configured with capability to compute fractional flowreserve using any of the three ways. In one embodiment, the portabledisplay unit 104 can be configured to automatically use one of the threeways of computing fractional flow reserve. In one embodiment, theportable display unit 104 can be configured to automatically select oneof the three ways of computing fractional flow reserve when a conditionis present and to automatically select another of the three ways ofcomputing fractional flow reserve when other conditions are present. Inone embodiment, the portable display unit 104 can be configured topermit a user to manually select one of the three ways of computingfraction flow reserve.

The disclosed technology measures pressure and calculates fractionalflow reserve (FFR). FFR is a calculation that has been clinicallydemonstrated to assist in determining whether to treat or not to treatan intermediate coronary lesion. Using the disclosed technology willthus assist a physician in determining what to do with an intermediatelesion. The disclosed FFR equations are exemplary and do not limit thescope of the disclosed technology. Other ways to compute FFR arecontemplated to be within the scope of the disclosed technology.

The illustrations, embodiments, and specifications disclosed herein areexemplary and do not limit the spirit and scope of the disclosedtechnology. Combinations of one or more disclosed embodiments orspecification, or portions of one or more embodiments or specifications,are contemplated as being within the scope of the disclosed technology.

What is claimed is:
 1. A portable display device for displayingfractional flow reserve information, the portable display devicecomprising: a housing; a display screen in the housing in a foldedposition before use, wherein pivoting the display screen from the foldedposition to an open position acts as an ON switch, wherein the portabledisplay device has no capability of being turned off after the displayscreen is pivoted to the open position; and a processor within thehousing, the processor configured to perform fractional flow reservecomputations based on sensor measurements and to cause the displayscreen to display fractional flow reserve information based on thefractional flow reserve computations.
 2. The portable display device ofclaim 1, further comprising at least one non-rechargeable battery withinthe housing, wherein after the display screen is pivoted to the openposition, the at least one non-rechargeable battery operatescontinuously until it is depleted based on the portable display devicehaving no capability of being turned off after the display screen ispivoted to the open position.
 3. The portable display device of claim 1,further comprising a connector configured to be attachable to anddetachable from a guidewire, the connector configured to establish acommunicative connection with the guidewire when the guidewire isattached to the connector.
 4. The portable display device of claim 1,further comprising a wireless receiver configured to wirelessly receivethe sensor measurements from a guidewire.
 5. The portable display deviceof claim 1, wherein the sensor measurements are pressure measurements.6. The portable display device of claim 5, wherein the fraction flowreserve computations are computed based on: recorded pressuremeasurements proximal to a first stenosis, and distal pressuremeasurements distal to the first stenosis, the distal pressuremeasurements being measured after the recorded pressure measurements arerecorded.
 7. The portable display device of claim 6, wherein the distalpressure measurements are measured distal to the first stenosis andproximal to a second stenosis.
 8. The portable display device of claim6, wherein: the recorded pressure measurements are measured proximal tothe first stenosis and proximal to a second stenosis, and the distalpressure measurements are measured distal to the first stenosis anddistal to the second stenosis.
 9. The portable display device of claim5, wherein the fraction flow reserve is computed based on: recordedpressure measurements distal to a first stenosis, and proximal pressuremeasurements proximal to the first stenosis, the proximal pressuremeasurements being measured after the recorded pressure measurements arerecorded.
 10. The portable display device of claim 9, wherein theproximal pressure measurements are measured proximal to the firststenosis and distal to a second stenosis.
 11. The portable displaydevice of claim 9, wherein: the recorded pressure measurements aremeasured distal to the first stenosis and distal to a second stenosis,and the proximal pressure measurements are measured proximal to thefirst stenosis and proximal to the second stenosis.
 12. The portabledisplay device of claim 1, further comprising a communications portconfigured to receive communications that include pressure measurements.13. The portable display device of claim 12, wherein the processor isconfigured to perform the fractional flow reserve computations furtherbased on the pressure measurements received at the communications port.14. The portable display device of claim 12, wherein the processor iscapable of performing the fractional flow reserve computations in atleast two ways comprising: performing the fractional flow reservecomputations based on only the sensor measurements, and performing thefractional flow reserve computations based on the sensor measurementsand based on pressure measurements received at the communications port.15. The portable display device of claim 14, wherein the processor isconfigured to automatically select one of the at least two ways ofperforming the fractional flow reserve computations.
 16. The portabledisplay device of claim 14, wherein the processor is configured toreceive a user selection of one of the at least two ways of performingthe fraction flow reserve computations.
 17. A handheld display devicefor displaying fractional flow reserve information, the handheld displaydevice comprising: a housing; a display screen in the housing in afolded position before use, wherein pivoting the display screen from thefolded position to an open position acts as an ON switch, wherein thehandheld display device has no capability of being turned off after thedisplay screen is pivoted to the open position; and a processor withinthe housing, the processor configured to perform fractional flow reservecomputations based on sensor measurements and to cause the displayscreen to display fractional flow reserve information based on thefractional flow reserve computations.
 18. The handheld display device ofclaim 17, wherein the housing has a length equal to or less than 30 cm,a width equal to or less than 30 cm, and a depth equal to or less than30 cm.
 19. A portable display device comprising: a housing; a displayscreen in the housing in a folded position before use, wherein pivotingthe display screen from the folded position to an open position acts asan ON switch, wherein the portable display device has no capability ofbeing turned off after the display screen is pivoted to the openposition; and a processor within the housing, the processor configuredto perform computations based on sensor measurements from a guidewireand to cause the display screen to display information based on thecomputations.